Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19

COVID-19 Clinical Trial

— COVID-19  

Official title:

An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects Positive With SARS-CoV-2 With Mild Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04344457
• Other study ID #: HIZ-PRC-COVID-19
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 16, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: June 2020
• Source: Perseverance Research Center, LLC
• Contact: Nicole C Hank, PhD,MCR,MHSM
• Phone: 4804716132
• Email: nhank[@]prcresearcheducation.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona.

This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2

Description:

COVID-19 has become a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%); therefore, interventions to decrease the incidence and severity of COVID-19 are emergently needed. In Maricopa County there has yet to be a clinical trial to evaluate people who are SARS-CoV-2 positive with mild symptoms. This study will measure the improvement of COVID-19 disease status as measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free on 14 days of a cocktail therapy of Hydroxychloroquine, Indomethacin and Zithromax.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. > 18 years of age

2. Willing and able to provide written informed consent prior to performing study procedures

3. Confirmed Sars-CoV2 infection by PCR

4. Have mild symptoms of Sars-CoV2

5. Must show documentation of Sars-CoV2 to screening visit

6. Must have had recent hematology and chemistry results

7. Must be able to take heart rate daily

8. Must agree to Skype/Facetime daily

9. Must agree to take temperature daily

10. Must agree not to enroll in another study of an investigational agent prior to completion of Day 14 of treatment.

Exclusion Criteria:

1. Known to be allergic to research drugs or drug excipients

2. Incapable of providing informed consent

3. Participation in any other clinical trial of an experimental treatment for Sars-CoV2 infection

4. Pregnancy, possible pregnancy or breast feeding

5. Prolonged QT interval (>450)

6. Moderate to severe symptoms of Sars-CoV2

7. Renal failure

8. Hepatic failure

9. NSAID use

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Hydroxychloroquine
200 mg PO BID 7 days
• Indomethacin
50 mg PO TID 14 Days
• Zithromax Oral Product
500 mg PO QD 3 Days

Locations

Country	Name	City	State
United States	Covidcraz 19, Llc	New Orleans	Louisiana
United States	Perseverance Research Center	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Perseverance Research Center, LLC	Athena Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of clinical status	measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free	up to 28 days
Secondary	Time of clinical recovery of fever	the time of normalization of fever as measured by daily temperature ( - =36.6°C or -axilla, =37.2 °C oral or =37.8°C rectal or tympanic)	up to 15 days
Secondary	Time of clinical recovery of cough	the time of alleviation of cough as measured by self reported visual analog scale (VAS) cough scale. 1=no cough, 2-3=cough sometimes, 4-6=have a cough but can still do things, 7-8=persistent cough, prevents from doing things, 9-10=cough presents a great deal of discomfort	up to 28 days
Secondary	Safety as determined by changes in QTC intervals measured by ECG	to determine the safety of these therapies in combination	up to 15 days
Secondary	Safety as determined by presence of side effects	to assess the presence or absence of side effects and whether they are tolerable	up to 15 days
Secondary	Time to improvement	improvement in Wisconsin Upper Respiratory Symptom Survey (WURSS-44) 0 to 7 scale, with 0 = Do not have, 1 = Very mild, 3 = Mild, 5 = Moderate, 7 = Severe	up to 28 days

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